Hyderabad, Nov 17 Aurobindo Pharma’s China plant has received the European Union’s Good Manufacturing Practices (GMP) approval and is fully ready now.
“The China plant is fully installed and has received EU’s GMP approval. It is expected to start revenue generation from the end of the fourth quarter of FY24 or early in the first quarter of FY25,’‘ Santhanam Subramanian, CFO, Aurobindo Pharma, said.
The company is in the process of manufacturing the exhibit batches and plans to file around five products from the China plant, and to start with the European dispatches, because it takes “quite a lot of time’‘ to get approval from Chinese regulators.
Other plants
“The other plants, the Pen-G plant and the 6-APA plant, are under installation and are expected to be operational from Q4 FY24 or Q1 FY25,’‘ he said in the earnings call.
``Further, we are conducting clinical studies for our biosimilar products and the plant is expected to be commissioned by FY25 or early FY26,’‘ he said.
With these initiatives, including commercialisation of the Pen-G plant and other projects over a period of time and stabilisation of manufacturing processes, the Hyderabad-based drug-maker expects the base EBITDA margin to improve, considering the current market conditions.
Biosimilars
“This margin is without considering the margin for biosimilars. We are strongly focused on biosimilars and peptides, and these are significant levers for the future,’‘ the CFO said.
Strategic partnerships like Merck, announced recently by the company, would continue to fuel growth and margins beyond FY25, he added.
Aurobindo Pharma’s Q1 net up 9.7 per cent at Rs 570 crore
According to Satakarni Makkapati, CEO of Aurobindo Biosimilars, Vaccines and Peptide Businesses, the limited letter of intent that Auronbindo signed with the MSD entity allows it to create infrastructure for contract manufacturing of innovator biologics. The market for originator biologics right now is about $300 billion to $350 billion.
“With more biologics approvals and their success in treating debilitating diseases worldwide, the need for reliable manufacturing, improving lead time efficiencies, and reducing supply chain lengths is becoming more relevant than ever,’‘ he said.
The biologics contract manufacturing industry is growing immensely and is poised to grow to about $30 billion to $40 billion by 2030, he added.
Aurobindo Pharma gets USFDA approval for Saxagliptin tablets, plans immediate launch
Aurobindo will continue to explore opportunities for any bolt-on acquisition aligned with its strategy, especially acquisition of ANDAs and market authorisation based on market opportunities, thereby, reducing the gestation period, he added.
In the second quarter ended September 30, 2023, Aurobindo registered revenue of Rs 7,219 crore, a 26 per cent increase, compared to the same quarter last year. The EBITDA before forex and other income grew by 67.7 per cent year-on-year and by 21.9 per cent quarter-on-quarter to Rs 1,403 crore.
The EBITDA margin for the quarter was at 19.4 per cent against 16.8 per cent for the last quarter. Net profit increased by 83.6 per cent year-on-year and by 31.7 per cent quarter-on-quarter, to Rs 752 crore.